What Is Leqvio? Uses, Dosage, and What You Need to Know in 2026

Leqvio is a prescription medication approved by the FDA on December 22, 2021 to lower LDL cholesterol — the "bad" cholesterol linked to heart disease and stroke. It belongs to an entirely new class of drugs called small interfering RNA (siRNA) therapies, making it unlike any other cholesterol medication available today. Here's what you need to know.

What Is Leqvio (Inclisiran)?

Leqvio's generic name is inclisiran. It is manufactured by Novartis Pharmaceuticals Corporation and is available only as a brand-name product — there is no generic. It is given as a subcutaneous (under the skin) injection of 284 mg, administered by a healthcare provider at a clinic.

Leqvio is classified as an siRNA directed to PCSK9 mRNA. It works by preventing the liver from making a protein called PCSK9 that normally interferes with the body's ability to remove LDL cholesterol from the blood. By blocking PCSK9 production at the genetic level, Leqvio allows more LDL receptors to function on liver cells, dramatically increasing LDL-C clearance.

What Is Leqvio Used For?

Leqvio is FDA-approved for adults with:

• Primary hyperlipidemia — including heterozygous familial hypercholesterolemia (HeFH), a genetic condition that causes extremely high LDL-C
• Atherosclerotic cardiovascular disease (ASCVD) — including history of heart attack, stroke, coronary artery disease, or other vascular disease requiring further LDL-C reduction

It is used as an adjunct to diet and exercise, and can be used with or without statins. Patients who cannot tolerate statins are also candidates for Leqvio.

Leqvio Dosage: How Much and How Often?

Leqvio comes in a fixed dose of 284 mg (1.5 mL) in a single-use prefilled syringe. There is no titration or dose adjustment.

The dosing schedule is:

1. Initial dose (Day 1): first injection given by your healthcare provider
2. Second dose (Month 3): loading dose given 3 months after the first
3. Maintenance doses (every 6 months): once every 6 months thereafter

This twice-yearly maintenance schedule is one of Leqvio's defining advantages. No other LDL-lowering therapy requires only two doses per year, which greatly improves adherence compared to daily pills or more frequent injections.

How Effective Is Leqvio?

In the ORION clinical trial program (three Phase 3 randomized controlled trials, 3,457 participants), Leqvio achieved:

• 51% average LDL-C reduction at Day 510 in the ASCVD population (Study 1)
• 46% average LDL-C reduction at Day 510 in a second ASCVD cohort (Study 2)
• 40% average LDL-C reduction in HeFH patients (Study 3)

LDL-C reduction was apparent within just 14 days of the first dose and was sustained throughout the 6-month dosing interval.

Key Facts About Leqvio at a Glance

• Brand name: Leqvio (pronounced "leck-vee-oh")
• Generic name: inclisiran
• Drug class: siRNA / PCSK9 inhibitor (RNA interference)
• Manufacturer: Novartis Pharmaceuticals Corporation
• Controlled substance: No
• Dosage form: 284 mg/1.5 mL subcutaneous injection
• Dosing frequency: Initial, then 3 months, then every 6 months
• Administration: In-office injection by healthcare provider only (not self-administered)
• LDL-C reduction: ~50% (range 40–51% in clinical trials)

Who Should NOT Take Leqvio?

Do not use Leqvio if you have had a serious allergic reaction (anaphylaxis or angioedema) to inclisiran or any ingredient in the formulation. Leqvio should not be used during pregnancy. It has not been studied in patients under 18 years of age.

For a full breakdown of side effects, see our guide to Leqvio side effects.

Want to understand exactly how Leqvio works? Read our plain-English explanation of Leqvio's mechanism of action.